Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077684
Company: BARR LABS INC

Products on ANDA 077684

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TRETINOIN	TRETINOIN	10MG	CAPSULE;ORAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077684

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/21/2007	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077684s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/24/2009	SUPPL-3	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 077684

TRETINOIN

CAPSULE;ORAL; 10MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TRETINOIN	TRETINOIN	10MG	CAPSULE;ORAL	Prescription	No	AB	077684	BARR LABS INC
TRETINOIN	TRETINOIN	10MG	CAPSULE;ORAL	Prescription	No	AB	201687	ENDO OPERATIONS
TRETINOIN	TRETINOIN	10MG	CAPSULE;ORAL	Prescription	No	AB	208279	GLENMARK PHARMS LTD